- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00444574
Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD
June 23, 2015 updated by: Noven Therapeutics
A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) vs. CONCERTA® in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a phase III, randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose optimization study designed to evaluate the safety and efficacy of MTS (12.5, 18.75, 25, and 37.5 cm2) compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with attention deficit hyperactivity disorder (ADHD).
Study Type
Interventional
Enrollment (Actual)
282
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- male or female aged 6-12 years
- females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline.
- a primary diagnosis of ADHD based on a detailed psychiatric evaluation
- a total score of =>26 on the ADHD-RS-IV at the Baseline Visit
- a minimum level of intellectual functioning, as determined by an IQ (based on KBIT) score of 80 or above
- no comorbid illness that could affect safety or tolerability or in any way interfere with the subject's participation in the study.
EXCLUSION CRITERIA:
- a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD) with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
- a known non-responder to psychostimulant treatment
- overweight (Body Mass Index (BMI)-for-age >90th percentile)
- a history of seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- Conduct Disorder.
- Subject has taken an investigational drug within 30 days prior to Screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Methylphenidate Transdermal System
Methylphenidate 2.7mg, 41.3mg, 55mg, and 82.5mg patches for 7 weeks
|
The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
Other Names:
|
Placebo Comparator: Placebo
Placebp matching MTS and Concerta for 7 weeks
|
The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
Other Names:
|
Active Comparator: Concerta
Methylphenidate HCL 18mg tablet 7 weeks
|
The primary objective of this study was to evaluate, under controlled conditions, the safety and efficacy of MTS compared to placebo with reference to CONCERTA
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary objective of this study is to evaluate, under controlled conditions, the safety and efficacy of SPD485 (MTS) compared to placebo with reference to CONCERTA®, as determined by the change in the clinician completed ADHD-RS-IV at each visit.
Time Frame: 7 weeks
|
7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CTRS-R, CPRS-R, CGI, PGA scores
Time Frame: 7 weeks
|
7 weeks
|
Treatment emergent AEs, dermal evaluations, PK
Time Frame: 7 weeks
|
7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
March 6, 2007
First Submitted That Met QC Criteria
March 7, 2007
First Posted (Estimate)
March 8, 2007
Study Record Updates
Last Update Posted (Estimate)
June 25, 2015
Last Update Submitted That Met QC Criteria
June 23, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
Other Study ID Numbers
- SPD485-302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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